buprenorphine and naloxone tablet
1 INDICATIONS AND USAGE Buprenorphine and naloxone sublingual tablet is indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual tablet contains buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and is indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual tablet should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )
sun pharmaceutical industries limited
ROUND ORANGE 970
970 ROUND ORANGE
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16 HOW SUPPLIED / STORAGE AND HANDLING
BUPRENORPHINE AND NALOXONE sublingual tablets containing 2 mg buprenorphine with 0.5 mg naloxone (in terms of free base, equivalent to 2.16 mg buprenorphine hydrochloride USP and 0.61 mg naloxone hydrochloride dihydrate USP) are uncoated, round, biconvex, orange, sublingual tablets, debossed with ‘969’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap……....………..NDC 62756-969-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-969-64
BUPRENORPHINE AND NALOXONE sublingual tablets containing 8 mg buprenorphine with 2 mg naloxone (in terms of free base, equivalent to 8.64 mg buprenorphine hydrochloride USP and 2.44 mg naloxone hydrochloride dihydrate USP) are uncoated, round, biconvex, orange, sublingual tablets, debossed with ‘970’ on one side and plain on other side and are supplied as: Bottles of 30 with child-resistant cap…....…………..NDC 62756-970-83 Unit-Dose blister pack of 30 (3×10) tablets ……..... NDC 62756-970-64 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Store
BUPRENORPHINE AND NALOXONE sublingual tablets securely and dispose of properly [see Patient Counseling Information (17)].
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